Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000666628
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
19/10/2005
Date last updated
19/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of 8 weeks open label aripiprazole as augmentation therapy in Bipolar II disorder
Scientific title
Efficacy of 8 weeks open label aripiprazole as augmentation therapy in Bipolar II disorder
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar II Disorder 814 0
Condition category
Condition code
Neurological 878 878 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Addition of trial medication (aripiprazole) to existing treatment for a period of 8 weeks
Intervention code [1] 506 0
Treatment: Drugs
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1132 0
Change in Young Mania Rating Scale
Timepoint [1] 1132 0
Measured at weeks 2, 4, and 8
Primary outcome [2] 1133 0
Change in Montgomery Asberg Depression Rating Scale
Timepoint [2] 1133 0
Measured at weeks 2, 4, and 8
Secondary outcome [1] 2085 0
Clinical Global Impression (CGI).
Timepoint [1] 2085 0
Measured at weeks 2, 4, and 8.
Secondary outcome [2] 2086 0
Visual analogue scales (0 - 10) for mania and depression.
Timepoint [2] 2086 0
Daily Log
Secondary outcome [3] 2087 0
Mood and sleep chart
Timepoint [3] 2087 0
Daily Log

Eligibility
Key inclusion criteria
A DSM-IV diagnosis of Bipolar I disorder, orA diagnosis of Bipolar II (with 2 days hypomania rather than the 4 day minimum as defined by DSM-IV); Mood episodes over the previous 12 months (one hypomania); Regarded as being unstable by their treating clinician to warrant an additional mood stabiliser;Female patients of childbearing potential must use a medically accepted means of contraception;Provide written informed consent;Able to understand and comply with the requirements of the study.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of any prohibited medication, including antipsychotic meds other than aripiprazole, within 7 days of Week 4Use of depot antipsychotics during last 8 weeks. ECT within past 3 monthsPregnancy or lactation, or intention to become pregnantUnstable or inadequately treated clinically significant medical illness, as judged by the investigatorCurrent DSM-IV diagnosis of MDD, schizophrenia or schizoaffective disorder or organic mental disorder or substance or alcohol dependence at enrolment. Co-morbid anxiety disorder may be includedJudged to be at significant risk for suicide.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 968 0
Commercial sector/Industry
Name [1] 968 0
Bristol-Myers Squibb Pharmaceuticals
Country [1] 968 0
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb Pharmaceuticals
Address
Country
United States of America
Secondary sponsor category [1] 836 0
None
Name [1] 836 0
nil
Address [1] 836 0
Country [1] 836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2273 0
The Melbourne Clinic
Ethics committee address [1] 2273 0
130 Church Street Richmond VIC, 3121
Ethics committee country [1] 2273 0
Australia
Date submitted for ethics approval [1] 2273 0
Approval date [1] 2273 0
Ethics approval number [1] 2273 0

Summary
Brief summary
Study approved
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35684 0
Address 35684 0
Country 35684 0
Phone 35684 0
Fax 35684 0
Email 35684 0
Contact person for public queries
Name 9695 0
Professor Isaac Schweitzer
Address 9695 0
The Melbourne Clinic
130 Church Street
Richmond VIC 3121
Country 9695 0
Australia
Phone 9695 0
+61 3 04209350
Fax 9695 0
Email 9695 0
schweitz@unimelb.edu.au
Contact person for scientific queries
Name 623 0
Professor Chris Pratt
Address 623 0
The Melbourne Clinic
130 Church Street
Richmond VIC 3121
Country 623 0
Australia
Phone 623 0
+61 3 04209350
Fax 623 0
Email 623 0
chris.pratt@healthscope.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.